Therapy Detail

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Therapy Name Alpelisib + Everolimus
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Alpelisib Piqray BYL719 PIK3CA inhibitor 23 Piqray (alpelisib) is a selective PIK3CA inhibitor that blocks activation of the PI3K signaling pathway and inhibits tumor growth (PMID: 23726034). Piqray (alpelisib) is FDA approved in combination with fulvestrant for use in postmenopausal women, and men, with advanced or metastatic hormone receptor (HR)-positive, ERBB2 (HER2)-negative, PIK3CA-mutant breast cancer (FDA.gov).
Everolimus Afinitor RAD001|Zortress mTORC1 Inhibitor 9 Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex who have subependymal giant cell astrocytoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PTEN dec exp triple-receptor negative breast cancer predicted - sensitive Alpelisib + Everolimus Preclinical - Pdx & cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) synergistically inhibited cell viability of PTEN-deficient triple-negative breast cancer patient-derived cells in culture, and led to inhibition of tumor growth in patient-derived xenograft (PDX) models (PMID: 36900375). 36900375
PIK3CA amp PTEN H123P triple-receptor negative breast cancer predicted - sensitive Alpelisib + Everolimus Preclinical - Pdx & cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) synergistically inhibited cell viability of patient-derived triple-negative breast cancer cells harboring PIK3CA amplification and PTEN H123P in culture, and led to inhibition of tumor growth in a patient-derived xenograft (PDX) model (PMID: 36900375). 36900375
PIK3CA E545K estrogen-receptor positive breast cancer predicted - sensitive Alpelisib + Everolimus Preclinical - Patient cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) inhibited cell viability of patient-derived ESR1 (ER)-positive breast cancer cells harboring PIK3CA E545K in culture (PMID: 36900375). 36900375
PIK3CA H1047R estrogen-receptor positive breast cancer predicted - sensitive Alpelisib + Everolimus Preclinical - Patient cell culture Actionable In a preclinical study, combination treatment with Piqray (albelisib) and Afinitor (everolimus) synergistically inhibited cell viability of patient-derived ESR1 (ER)-positive breast cancer cells harboring PIK3CA H1047R and ESR1 (ER alpha) Y537S in culture (PMID: 36900375). 36900375

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02077933 Phase I Alpelisib + Everolimus Alpelisib + Everolimus + Exemestane Study of Safety and Efficacy of BYL719 With Everolimus or BYL719 With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors Completed USA | NLD | ITA | GBR | FRA | ESP | DEU 2


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